WO2011100869A1 - Stent biocompatible avec éléments de fixation coulissants - Google Patents

Stent biocompatible avec éléments de fixation coulissants Download PDF

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Publication number
WO2011100869A1
WO2011100869A1 PCT/CN2010/070701 CN2010070701W WO2011100869A1 WO 2011100869 A1 WO2011100869 A1 WO 2011100869A1 CN 2010070701 W CN2010070701 W CN 2010070701W WO 2011100869 A1 WO2011100869 A1 WO 2011100869A1
Authority
WO
WIPO (PCT)
Prior art keywords
bracket
stent
buckle
outer frame
head
Prior art date
Application number
PCT/CN2010/070701
Other languages
English (en)
Chinese (zh)
Inventor
孙锟
孙康
冯其茂
姜闻博
窦红静
李伟
Original Assignee
上海交通大学医学院附属新华医院
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 上海交通大学医学院附属新华医院 filed Critical 上海交通大学医学院附属新华医院
Priority to PCT/CN2010/070701 priority Critical patent/WO2011100869A1/fr
Publication of WO2011100869A1 publication Critical patent/WO2011100869A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/848—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents having means for fixation to the vessel wall, e.g. barbs
    • A61F2002/8483—Barbs

Definitions

  • This invention relates generally to the field of medical devices, and more particularly to a novel slider bioresorbable stent for use in dilating blood vessels, as well as in stenotic sites of organs such as the trachea, esophagus, urethra, and biliary tract. Background technique
  • Congenital heart disease is the most common cardiovascular disease in childhood, with an incidence rate of 0.678% of live births.
  • RV-PA tubing right ventricle-pulmonary artery artificial conduit
  • vascular stents are all woven from metal. After the stent is implanted, it supports the vascular wall at an early stage to prevent retraction. With the endothelialization of the stent and the reconstruction of the vessel wall in the later stage, the stent only needs temporary support. However, the size of the metal stent after implantation is not changed with the growth of the blood vessel, and it is likely to cause artificial stenosis due to mismatch with the size of the blood vessel. Metal stents also have the following defects: (1) long-term antiplatelet therapy is easy to form thrombus; (2) lifelong retention in the human body, affecting subsequent possible surgical treatment; (3) appearing in nuclear magnetic resonance and CT examination Artifacts. Therefore, bioresorbable stents are bound to be the most promising.
  • the current research is mainly poly-L-lactic acid, but also polyoxycyclohexanone and polycaprolactone. These materials gradually degrade in the body, participate in metabolism in the body and are excreted; It has been approved for FDA approval and can be implanted in the body.
  • the Igaki-Tamai stent is designed for bioabsorbable stents: Zig-Zag shape design; REVA stent: The entire stent has a slide & lock design; Four-leaf structural bracket: It is based on four leaves made of fiber The structure, the coil continues to surround the entire body of the stent, and when the stent is fully expanded, it has a spiral coil plus three longitudinal fibers.
  • the common feature of these brackets is that they are all complete cylindrical types before expansion, but all have problems, that is, the support force of all the brackets is insufficient, and the elastic contraction of the brackets is easy to occur. Summary of the invention
  • the object of the present invention is to solve the bottleneck of the interventional treatment method for vascular stenosis in infants and young children, and the problem of insufficient support force of the bioabsorbable stent; and to provide a novel bioabsorbable stent, which not only has the support of improving the support of the stent but also has completely different new types.
  • the shape of the slider design is to solve the bottleneck of the interventional treatment method for vascular stenosis in infants and young children, and the problem of insufficient support force of the bioabsorbable stent; and to provide a novel bioabsorbable stent, which not only has the support of improving the support of the stent but also has completely different new types.
  • the invention provides a novel slider bioresorbable stent, which is a sheet shape before implantation, comprises a stent body with a mesh structure, a stent head which acts as a sliding buckle at one end of the stent body and during the curling process of the stent
  • the bracket body is fixed into a tubular bracket buckle. According to the position of the bracket buckle, it is divided into three types: buckle type, edge slide type and intermediate slide type.
  • a bioabsorbable slider bracket in accordance with one embodiment of the present invention is shown.
  • the bracket includes: a flat bracket body, a bracket head at one end of the body, and a bracket buckle.
  • a row of mesh holes is arranged on the body portion of the bracket, and the sizes of the mesh holes may be the same or different.
  • each mesh size is evenly distributed, e.g., the mesh size is 0.5-3 mm.
  • the mesh can be of any shape, including circles, ovals, squares, rectangles, triangles, polygons, and the like. In one embodiment of the invention, the mesh is circular.
  • the bracket buckle is located near the head of the bracket, as shown in Fig.
  • protruding buckles which together with the outer frame constitute the slider device of the present invention.
  • the length of the raised buckle is 0.5-lmm, at an angle relative to the plane of the stent, typically 20-40 degrees. However, those skilled in the art will understand that it can be any other angle.
  • the size of the outer frame is adapted to the size of the body of the bracket, so that during the crimping process of the bracket, the inner protruding buckle can be strictly slid along the length of the sheet to avoid misalignment.
  • the tabs of the protrusions can be arbitrarily inserted into any of the rows of meshes during sliding, so that the sheets can be fixed into a tubular shape.
  • a bioabsorbable slider bracket according to another embodiment of the present invention is shown.
  • the bracket The utility model comprises a flat bracket body, a bracket head at one end of the body and a bracket buckle.
  • the bracket includes a longitudinal axis Z extending parallel to the head of the bracket and a transverse axis X extending perpendicular to the head of the bracket, as shown.
  • a row of mesh holes is arranged on the body portion of the bracket, and the sizes of the mesh holes may be the same or different.
  • each mesh size is evenly distributed, for example, the mesh size is 0.5-3 mm.
  • the mesh can be of any shape, including circles, ovals, squares, rectangles, triangles, polygons, and the like.
  • the mesh is circular.
  • the bracket head includes an outer frame that is sized to fit the body of the bracket.
  • the bracket buckle is embodied as teeth on both sides of the bracket body, the bracket body can pass through the outer frame during the curling of the bracket, and the tooth structures on both sides can follow the outer frame Both edges slide.
  • the teeth engage the outer frame to enable the sheet to be fixed into a tubular shape.
  • the teeth have a size of 0.1 mm. All of the teeth extend away from the head of the stent at an angle relative to the transverse axis of the stent, for example 30-60 degrees. In one embodiment of the invention, the teeth are at an angle of 30 degrees with respect to the transverse axis of the stent.
  • a bioabsorbable slider bracket according to still another embodiment of the present invention is shown.
  • the bracket includes a flat bracket body, a bracket head at one end of the body, and a bracket buckle.
  • the bracket includes a longitudinal axis Z that extends parallel to the head of the bracket and a transverse axis X that extends perpendicular to the head of the bracket.
  • a row of mesh holes is arranged on the body portion of the bracket, and the sizes of the mesh holes may be the same or different.
  • each mesh size is evenly distributed, for example, the mesh size is 0.5-3 mm.
  • the mesh can be of any shape, including circles, ovals, squares, rectangles, triangles, polygons, and the like.
  • the mesh is circular.
  • the bracket head includes a buckle structure between the outer frame and the outer frame, and both ends of the buckle are connected with the outer frame.
  • the buckle structure has a length of 0.5-lmm.
  • the body of the stent includes teeth corresponding to the buckle structure, the teeth extending away from the head of the stent.
  • the teeth have a size of 0.1 mm.
  • the teeth are at an angle relative to the transverse axis of the stent, for example at an angle of 30-60 degrees. In one embodiment of the invention, the teeth are at an angle of 30 degrees with respect to the transverse axis of the stent.
  • the tooth structure slides along both sides of the buckle structure in the outer frame of the bracket head, and during the sliding process, the tooth buckles the buckle structure of the outer frame, so that the sheet can be fixed Tubular.
  • the bracket cannot be retracted after being fastened.
  • the stent is tightly rolled up and attached to the balloon of the delivery device. After reaching the designated site, the balloon expands to expand the diameter of the stent and suck back the balloon. As the pressure bracket of the blood vessel wall is immediately buckled, it supports the blood vessel wall.
  • Materials for bioabsorbable stents include polylactic acid (PLA;), polydioxanone (PDO), polycaprolactone (PCL;), polyglycolic acid (; PGA;), polyhydroxybutyric acid ( ; PHB) and other high-molecular polymers and new polymers produced by copolymerization, blending, modification, etc. of different polymers.
  • PLA polylactic acid
  • PDO polydioxanone
  • PCL polycaprolactone
  • PCL polyglycolic acid
  • PGA polyhydroxybutyric acid
  • PHB polyhydroxybutyric acid
  • the fabrication of the stent includes molding, machine printing, laser engraving, and the like.
  • the unique slider design is unique. Before the expansion, other bioabsorbable stents are cylindrical, and the sliding-button bioabsorbable blood vessels are a sheet-like structure; after the stent is expanded, there is almost no elastic retraction, which significantly increases the radial support force of the stent.
  • the bioabsorbable vascular stents of the present invention have a completely new concept. Firstly, before the expansion, the metal stents are all cylindrical, and the sliding-button bioabsorbable blood vessels are in a piece-like structure; the metal stents have different degrees of elastic retraction after expansion, and the stent has strong radial support force and almost no elasticity. Retracted. At present, the clinical metal stent is not a solution material, and the defects are:
  • FIG. 1 is a schematic view of a slider bracket according to an embodiment of the present invention.
  • FIG. 2 is a schematic view of a slider bracket according to an embodiment of the present invention.
  • FIG 3 is a schematic view of a slider bracket according to an embodiment of the present invention.
  • FIG. 4 is a photographic view of the slider holder of the present invention before implantation.
  • Figure 5 is a photographic view of the slider holder of the present invention after implantation. Specific example
  • Example 1 The in vitro simulated release of a polycaprolactone (PCL) snap-type stent was observed.
  • PCL Polycaprolactone
  • Vessel lumen diameter After the balloon is removed, the diameter of the vessel lumen at the stent is measured.
  • Acute elastic retraction rate of the stent (diameter when the stent is fully expanded - stent diameter after balloon removal y diameter when the stent is fully expanded).
  • Evaluation criteria Success: After the balloon is removed, the stent buckle is stuck; Failure: After the balloon is removed, the stent is not buckled and slides into the lumen.
  • PCL-type stents can be released under normal release pressure (10-14 atm), the stent can be successfully buckled, no stent curls into the lumen; the stent basically maintains a preset lumen diameter, with extremely low Acute elastic retraction rate (0.4%). Prove that this bracket design operation is feasible.
  • PCL Polycaprolactone
  • Vessel lumen diameter After the balloon is removed, the diameter of the vessel lumen at the stent is measured.
  • Acute elastic retraction rate of the stent (diameter when the stent is fully expanded - stent diameter after balloon removal y diameter when the stent is fully expanded).
  • Evaluation criteria Success: After the balloon is removed, the stent buckle is stuck; Failure: After the balloon is removed, the stent is not buckled and slides into the lumen.
  • PCL edge slide-type brackets can be released under normal release pressure (l l-15atm), the stent can be successfully buckled, no stent curls into the lumen; the stent basically maintains a preset lumen diameter, which is extremely low The acute elastic retraction rate (0.35 %). Prove that this bracket design operation is feasible.
  • PCL Polycaprolactone
  • Vessel lumen diameter After the balloon is removed, the diameter of the vessel lumen at the stent is measured.
  • Acute elastic retraction rate of the stent (diameter when the stent is fully expanded - stent diameter after balloon removal y diameter when the stent is fully expanded).
  • Evaluation criteria Success: After the balloon is removed, the stent buckle is stuck; Failure: After the balloon is removed, the stent is not buckled and slides into the lumen.
  • PCL intermediate slide-type brackets can be released under normal release pressure (1 1-15 atm), the stent can be successfully buckled, no stent curls into the lumen; the stent basically maintains a preset lumen diameter, with a pole Low acute elastic retraction rate (0.34%). Prove that this bracket design operation is feasible.
  • Vessel lumen diameter After the balloon is removed, the diameter of the vessel lumen at the stent is measured.
  • Acute elastic retraction rate of the stent (diameter when the stent is fully expanded - stent diameter after balloon removal y diameter when the stent is fully expanded).
  • Evaluation criteria Success: After the balloon is removed, the stent buckle is stuck; Failure: After the balloon is removed, the stent is not buckled and slides into the lumen.
  • PDO buckle-type stents can be released under normal release pressure (10-14atm), the stent can be successfully buckled, no stent curls into the lumen; the stent basically maintains a preset lumen diameter, with very low acute Elastic retraction rate (0.5%). Prove that this bracket design operation is feasible.
  • Vessel lumen diameter After the balloon is removed, the diameter of the vessel lumen at the stent is measured.
  • Acute elastic retraction rate of the stent (diameter when the stent is fully expanded - stent diameter after balloon removal y diameter when the stent is fully expanded).
  • Evaluation criteria Success: After the balloon is removed, the stent buckle is stuck; Failure: After the balloon is removed, the stent is not buckled and slides into the lumen.
  • the PDO edge slider type bracket can be released under normal release pressure (10-14atm), the bracket can be successfully buckled, no bracket curls into the lumen; the stent basically maintains the preset lumen diameter, which has extremely low Acute elastic retraction rate (0.3%). Prove that this bracket design operation is feasible.
  • Vessel lumen diameter After the balloon is removed, the diameter of the vessel lumen at the stent is measured.
  • Acute elastic retraction rate of the stent (; diameter when the stent is fully expanded - stent diameter after balloon removal y diameter when the stent is fully expanded.
  • Evaluation criteria Success: After the balloon is removed, the stent buckle is stuck; Failure: After the balloon is removed, the stent is not buckled and slides into the lumen.
  • PDO intermediate slide-type brackets can be released under normal release pressure (10-16atm), the brackets can be successfully buckled, no brackets curl into the lumen; the stent basically maintains a preset lumen diameter, with extremely low Acute elastic retraction rate (0.43 %). Prove that this bracket design operation is feasible.
  • the porcine iliac artery was stented with a polydioxanone (PDO) edge slide-type stent to observe its efficacy.
  • PDO polydioxanone
  • Sample content 15 pigs, PDO slider bracket 20*6mm20.
  • Chloramphenicol 10mg/Kg The pig is anesthetized, tracheal intubation, ECG monitoring, routine disinfection without bacteria towel, through the left carotid artery, and placed into the 9F sheath.
  • the diameter of the stent is required to be 25% larger than the diameter of the blood vessel.
  • the stent delivery system was inserted along the guidewire into the target site, and the 12-15 atm*30 second expanded release stent. Intraoperative heparin 100U/Kg.
  • Acute elastic retraction rate (The diameter of the stent when the balloon is fully expanded - the diameter of the postoperative angiographic stent y. The diameter of the stent when the balloon is fully expanded.
  • Successful delivery rate of the delivery system success: the stent is delivered to the target site, the stent is not detached, the stent is accurately positioned, and the stent is fully expanded.
  • Figure 4 is a contrast image of the porcine artery before stent implantation to determine the site of stent implantation.
  • Figure 5 is a contrast image after stent implantation. As shown in the figure, the vessel wall is expanded by the stent and the stent vessel is unobstructed.
  • the patents, patent applications, publications and documents referred to herein are not an admission that any of the above-mentioned documents are prior art or the contents or dates of those publications or documents.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

La présente invention concerne un stent biocompatible avec éléments de fixation coulissants, qui comprend : un corps de stent avec une structure à mailles ; la tête de stent, qui se situe au niveau d'une extrémité du corps de stent et qui fait partie intégrante dudit corps de stent, et qui fournit un effet d'élément de fixation coulissant lorsque le stent est enroulé ; des attaches de stent, qui font partie intégrante du corps de stent et fixent la structure tubulaire du stent lorsqu'il est enroulé.
PCT/CN2010/070701 2010-02-22 2010-02-22 Stent biocompatible avec éléments de fixation coulissants WO2011100869A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/CN2010/070701 WO2011100869A1 (fr) 2010-02-22 2010-02-22 Stent biocompatible avec éléments de fixation coulissants

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/CN2010/070701 WO2011100869A1 (fr) 2010-02-22 2010-02-22 Stent biocompatible avec éléments de fixation coulissants

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WO2011100869A1 true WO2011100869A1 (fr) 2011-08-25

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0756853A1 (fr) * 1995-08-01 1997-02-05 Advanced Cardiovascular Systems, Inc. Stent composite en métal et polymère comportant un verrouillage pour l'administration de médicaments
US6793672B2 (en) * 1998-03-25 2004-09-21 Endotex Interventional Systems, Inc. Coiled sheet graft for single and bifurcated lumens and methods of making and use
CN101247778A (zh) * 2006-06-20 2008-08-20 雷瓦医药公司 滑动锁紧支架

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0756853A1 (fr) * 1995-08-01 1997-02-05 Advanced Cardiovascular Systems, Inc. Stent composite en métal et polymère comportant un verrouillage pour l'administration de médicaments
US6793672B2 (en) * 1998-03-25 2004-09-21 Endotex Interventional Systems, Inc. Coiled sheet graft for single and bifurcated lumens and methods of making and use
CN101247778A (zh) * 2006-06-20 2008-08-20 雷瓦医药公司 滑动锁紧支架

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